A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

September 30, 2007

Study Completion Date

November 30, 2007

Conditions
Bipolar DisorderMood Disorders
Interventions
DRUG

Placebo

Daily for 3 weeks

DRUG

Quetiapine

400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks

DRUG

Paliperidone ER

3 to 12 mg daily, flexibly dosed, for 12 weeks

Trial Locations (47)

Unknown

Cerritos

Garden Grove

Oceanside

San Diego

Bradenton

Fort Lauderdale

Kissimmee

Maitland

South Miami

Tampa

Chicago

Indianapolis

Prairie Village

Lake Charles

Shreveport

Flowood

Clementon

Moore

Oklahoma City

Philadelphia

Memphis

Dallas

Athens

Alytus

Vilnius

Kazan'

Lipetsk

Moscow Region

Moscow Russia

Nizny Novgorod

Saratov

St-Petersburg Na

Incheon

Seoul

Changhua

Kaohsiung City

Taichung

Taipei

Ankara

Diyarbakır

Istanbul

Donetsk

Hlevakha

Kharkiv

Kiev

Odesa

Simferopol

All Listed Sponsors
lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT00309699 - A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder | Biotech Hunter | Biotech Hunter